Acetabular Fracture Clinical Trial
Official title:
Assessing Postoperative Reduction Following Acetabular Fracture Surgery
NCT number | NCT04073329 |
Other study ID # | AFRA |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 2023 |
Est. completion date | September 2024 |
It is widely accepted in the literature that quality of acetabular fracture reduction is one of the most important factor for the outcome. To obtain best results, anatomical reduction has to be obtained. Intra-operative radiographic assessment depends mainly on plain x-ray. Plain x-ray alone is not enough for post-operative assessment as it depends mainly on reduction of the dome with concentricity of the hip.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | September 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 65 Years |
Eligibility | Inclusion Criteria: - Isolated displaced acetabular fractures - Skeletally mature patients Exclusion Criteria: - Skeletally Immature |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Borrelli J Jr, Ricci WM, Steger-May K, Totty WG, Goldfarb C. Postoperative radiographic assessment of acetabular fractures: a comparison of plain radiographs and CT scans. J Orthop Trauma. 2005 May-Jun;19(5):299-304. — View Citation
Dodd A, Osterhoff G, Guy P, Lefaivre KA. Radiographic Measurement of Displacement in Acetabular Fractures: A Systematic Review of the Literature. J Orthop Trauma. 2016 Jun;30(6):285-93. doi: 10.1097/BOT.0000000000000538. Review. — View Citation
Verbeek DO, van der List JP, Helfet DL. Computed tomography versus plain radiography assessment of acetabular fracture reduction is more predictive for native hip survivorship. Arch Orthop Trauma Surg. 2019 Dec;139(12):1667-1672. doi: 10.1007/s00402-019-03192-w. Epub 2019 Apr 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ability of CT scans and plain radiographs to detect residual articular steps and gaps after healing of acetabular fractures managed by open reduction and internal fixation. | measurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with > 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as < 1 mm step and < 5 mm gap displacement and inadequate reductions as = 1 mm step and/or = 5 mm gap displacement. | 1 year |
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